About this trial
A bronchodilator reversibility test is widely used in the diagnosis and management of obstructive lung diseases.
Bronchodilators relieve symptoms in asthma and COPD. Traditionally, their effectiveness has been assessed using spirometric indices, particularly FEV₁. However, changes in FEV₁ often do not correlate well with patients' subjective experience of dyspnoea relief or with changes in small airway function.
Impulse oscillometry (IOS) provides an effort-independent assessment of respiratory mechanics during tidal breathing and is more sensitive to small airway dysfunction than spirometry. Despite this, the clinical utility of IOS in routine COPD and asthma assessment remains underexplored, and its relationship to both spirometric response and symptom relief is not fully established, and the Minimal Clinically Important Difference (MCID) for IOS parameters has not been firmly established. Determining the MCID is essential for interpreting individual patient responses in a clinically meaningful way and for guiding treatment decisions in both research and practice.
Hypothesis \& Aims
In patients with either asthma or COPD baseline values and bronchodilator responses are compared. More specifically, this study aims to:
1. assess baseline correlations: Evaluate the correlation between ΔX5-baseline (EFL expiratory flow limitation=small airway collapse during expiration), RV/TLC-baseline, X5-average at baseline, FEV1-baseline, VAS-dyspnea at baseline, and ACQ-6-baseline. 2. compare bronchodilator responses across methods: Examine the correlation between bronchodilator-induced changes in FEV₁ and IOS parameters (including both average and delta values) and explore their relationship with short-term changes in dyspnea. 3. establish clinical relevance: Determine the MCID for key IOS variables using both anchor-based and distribution-based approaches, anchored to perceived changes in lung symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent.
FEV1/Forced Vital Capacity (FVC) <0.7 at baseline (7)
Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26).
Asthma: Doctor diagnosed asthma
Disqualifiers
Patients aged less than 18 years old.
Not able to perform spirometry or impulse oscillometry.
Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28).
Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days.
Trial population
referred to Allergy and Lung Clinic Elsinore, Denmark for evaluation of Asthma and COPD (obstructive lung disease)
Trial design
Cohort
Prospective
Treatments tested in this trial
Bronchodilator
Diagnostic testClassic beta-2-reversibility test
Treatment groups
Trial outcomes
Primary outcomes
FEV1
Forced expiratory volumen in one second, L and % predicted
X5
Reactance at 5 Hz; kPa/L/s
Dyspnoea
Visual analog scale (0-100); 0 means no dyspnoea, and 100 means maximum dyspnoea
Secondary outcomes
R5
Resistance at 5 Hz, kPa/L/s and % predicted
R5-R20
Resistance in small airways, kPa/L/s
Fres
Resonant frequency (stiffness), Hz
AX
Area of reactance, kPa/L
Locations
Sponsors and contacts
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